MAUDE Adverse Event Report: REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS IV++ SCIG 26G 14MM HIGH FLO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number RMS-22614

Device Problems Difficult to Remove (1528); Patient Device Interaction Problem (4001); Physical Resistance/Sticking (4012)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

Patient reported that when she completes her infusion and tries to remove the needles ((b)(4)), the needles seem stuck in her body and she has a hard time taking them out she has to pull hard to remove and it hurts.She states it is just the needle and the adhesive is already removed.No missed dose; unknown if needles available for return; unknown lot/expiration.No further information known.Needles used to infuse hizentra 20% at above dose/frequency.Reported to (b)(6) by: patient/caregiver.

• Brand Name: IV++ SCIG 26G 14MM HIGH FLO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
• MDR Report Key: 12496121
• MDR Text Key: 272542124
• Report Number: MW5104054
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RMS-22614
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1